IRB Review. Reviewing IRB Institution represents and warrants that, without limitation of its review obligations set forth in Section 5.4 of the SMART Agreement, it will, in its review and oversight of the Study, take into consideration, account for and comply with applicable State and local laws, rules and regulations.
IRB Review. An appropriate University IRB designated under the University’s Federal-Wide Assurance, in accordance with U.S. Department of Health and Human Services regulations and Office for Human Research Protections administrative guidance, will be the IRB of record for the study. For the avoidance of doubt, such University IRB shall not be the IRB of record for any research conducted at or by the Facility other than the study conducted pursuant to this Agreement. The Facility will abide by all determinations of such University IRB (including the use of informed consent forms reviewed and approved by and on file with the University IRB) and will accept the final authority and decisions of such University IRB, including but not limited to directives to terminate participation in designated research activities. Consider provision whereby University is compensated for sending representatives to monitor study under local conditions (OHRP requirement to monitor study).
IRB Review. Mathematica has received IRB approval from Health Media Labs for the Evaluation’s research protocol. Mathematica will seek IRB approval by the College’s own IRB, as applicable.
IRB Review. The HRPP of the Receiving IRB performs a pre-review, following standard local procedures, before accepting responsibility for the protocol(s). The HRPP of the Receiving IRB may request the investigator to provide additional information or the Original IRB to provide local context information to the Receiving IRB. The Receiving IRB performs a complete review of the protocol(s), following standard procedures and using the relevant criteria for IRB approval. This may include the requirement for modifications or consent form changes. The Receiving IRB establishes a new approval period, including the frequency of continuing review.
